The purported benefits of 2’-fucosyllactose (2’-FL) to infant gut microbiota and immune development has piqued the interest of infant formula manufacturers, who have moved to develop this ingredient for impending product launches.
BASF, based in Ludwigshafen, Germany has developed the ingredient in-house using a specific HMO fermentation strain with plans to launch the ingredient for the infant nutrition market by early 2019.
“The development of HMOs is a breakthrough in the nutritional improvement of infant formulas. 2’-fucosyllactose will open up new opportunities to strengthen a child’s health beginning with infancy and even beyond that,” said François Scheffler, BASF Human Nutrition’s senior vice president.
Green light for large-scale production
Large-scale production of the ingredient has been ramped up ever since the ingredient received EU Novel Food approval for 2’-FL.
At a concentration 300 times higher in human milk compared to cow’s milk, 2’FL is the most abundant oligosaccharide in the group of 200 or so HMOs that have identified in human milk, consisting of 20 – 30 % of the total HMO content.
Along with Lacto-N-neotetraose ((LNnT), these remain the only two HMOs to be successfully commercialised.
“The HMO composition of human milk is complex and varies significantly among mothers, over the course of lactation and according to genetic set-up,” a spokesperson for BASF commented.
“The HMO concentration in early milk is highest and it declines about 30% over the course of lactation. In mature human milk, the content may still be as high as 5 – 20 grams per litre (g/l).
“The window of opportunity for microbiota modulation during early life starts in the prenatal phase and persists postnatally, when breast-feeding plays the most important role.”
2’-FL also represents a key ingredient in BASF's human nutrition brand Newtrition. The portfolio also includes essential nutrients including vitamins, carotenoids and high concentrate omega 3 fatty acids.
“We believe the inclusion of HMOs in infant formula will accelerate in the future – and could become as critical as the role DHA plays in the category, perhaps within a couple of years,” the spokesperson said.
Commenting on Newtrition’s offerings, Scheffler added that it was “committed to being at the scientific forefront of advancing nutrition and this launch is just the first step in the development of Newtrition’s HMO portfolio for infant nutrition initially and also dietary supplements in the near future.”
Jostling for position
The first half of this year has seen a number of EU regulatory approvals for synthetic HMOs, paving the way for their inclusion into a new wave of infant-focused formulas.
In May, Dutch-based FrieslandCampina Domo joined fellow formula manufacturers DuPont Nutrition and Health in March in gaining Novel Food approval in the EU for its HMO 2’-fucosyllactose (2’-FL).
Until recently, HMOs were not available in larger quantities from sources such as cow’s milk. The few that could be chemically synthesized were prohibitively expensive.
This was due to the complex structure of HMOs that required dedicated production technologies. On top of that, ingredients used in infant formula are subject to rigid quality and purity requirements.
Results of clinical trials and preclinical models have shown that 2’-FL has the potential to support and maintain immune modulatory functions for allergies and asthma, strengthen gut maturation, intestinal barrier and digestive comfort promoting a bifidogenic effect.
Asked about the possibility of making health claims for HMOs in the future, the spokesperson said that, “More and more studies are ongoing which look into the clinical relevance of deviations from a “normal” microbiota, especially during early life (e.g. dysbiosis preceding allergic diseases or metabolic syndrome).”
“We envisage that the potential of prebiotics in preserving a healthy microbiota will be viewed in light of the emerging science and that this will also translate into the opportunity to make specific claims.”